OnePoint HR and Management Consultants

Job Detail

Technical Manager - Medical Device (KSA) Technical Manager - Medical Device (KSA) Others

 

 

 

 

Brief Job Description:
1. Perform the Technical documentation review as per SFDA guidelines
2. Lead the team of technical reviewers
3. Prepare and execute the projects timely manner
4. Timely update of New / amendments Procedure in the internal system
5. Maintain and Qualify technical reviewers at regular intervals
 
Technical / Behavioral / Managerial / Critical Skills Desired:
Knowledge on Regulations requirements across Various countries ( USA, Europe , japan and other) on medical device , Managerial Skill , Analytical skills, technical document Report writing and review skill.
Indicate position for which incumbent should have potential to move fast:
Worked in NB as a Certifier / Lead auditor/ technical documentation reviewer and worked in Medical device industry in Quality, regulatory areas, handled international product certification/ registration of medical devices
Qualifications:
? Essential: College degree or masters in sciences. Good knowledge of medical devices, ISO 13485/ CE / FDA 510K K. Good communication skills both spoken and written English, proficiency in handling MS office.
? Desirable: work experience in middle east
 
Requirement: Willing to stay in Saudi Arabia for a long term.

 

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